MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. VENACURE 1470 PRO; SURGICAL LASER

Catalog Number	PDMS00252
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is insufficient information at this time to adequately evaluate the event.The adverse event described seems to have been predicted and included in the instruction manual of the device.It would be appropriate to carry out further investigations in order to exclude the correlation of a machine malfunction with the event that occurred.However, it is difficult at this time to determine whether there were errors at the level of clinical procedure, machine setting, as no details of the procedures performed were provided.We are currently in contact with the complainant to gather additional data.
Event or Problem Description
An angiodynamics territory manager reported an issue with a venacure 1470 pro laser.The end user reported that they recently had several patient have ehits {endothermal heat-induced thrombosis} during their 1 week follow ups post evlt.

• Brand Name: VENACURE 1470 PRO
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 19508093
• Report Number: 3004378299-2024-00005
• Device Sequence Number: 7498384
• Product Code: GEX
• UDI-Device Identifier: 08033945938925
• UDI-Public: 08033945938925
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PDMS00252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown